Professional Documents
Culture Documents
Research Proposal
This template is a framework to help you write down your proposal, in a way that will be acceptable
for submission to KRC committee.
Update the following information each time you submit a draft to your chairperson:
DRAFT NUMBER: 1 Type draft number here (1, 2, 3, Final)
DATE OF SUBMISSION: 10 03 2022
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CONTENTS
SUMMARY...........................................................................................................................................4
FULL PROPOSAL
1. LITERATURE REVIEW.............................................................................................................5
2. DEFINING THE RESEARCH...................................................................................................5
2.1. RESEARCH QUESTION............................................................................................................5
2.2. HYPOTHESIS...........................................................................................................................5
2.3. TWO-BY-TWO TABLE (START WITH THIS BUT YOU CAN LATER DELETE)..............5
2.4. AIMS AND OBJECTIVES..........................................................................................................5
3. STUDY METHODS.....................................................................................................................5
3.1. STUDY SETTING......................................................................................................................5
3.2. STUDY DESIGN.......................................................................................................................6
3.3. TARGET AND STUDY POPULATION..........................................................................................6
3.4. SAMPLING, SAMPLE SIZE AND POWER...................................................................................6
3.5. VARIABLES, DEFINITIONS AND DATA SOURCES.....................................................................7
3.6. DATA COLLECTION.................................................................................................................7
3.7. DATA MANAGEMENT..............................................................................................................7
3.8. DATA ANALYSIS PLAN.............................................................................................................8
4. ETHICAL CONSIDERATIONS.................................................................................................8
5. STRENGTHS AND LIMITATIONS..........................................................................................8
6. COMMUNICATION AND DISSEMINATION ........................................................................8
7. STUDY MANAGEMENT............................................................................................................9
7.1. ROLES AND RESPONSIBILITIES..............................................................................................9
7.2. PROJECT TIMELINES (SEE APPENDIX 5)...............................................................................9
7.3. REGULATORY ASPECTS...........................................................................................................9
8. REFERENCES............................................................................................................................9
9. APPENTICES (IF ANY) ....................................................................................................................9
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SUMMARY
BACKGROUND/LITERATURE REVIEW
Hypertension is a public health problem that affects almost a quarter of the world’s population and
is much more prevalent in developing countries than in developed countries (1). About 29% of
American adults suffer from high blood pressure, which increases with age, and about 1.8 million
people are added to these patients each year (2, 3). Population growth, aging, and unhealthy
behaviors such as poor nutrition, alcohol, physical inactivity, weight gain, and persistent stress are
some of the reasons for the hypertension (4).
Hypertension is a major risk factor for cerebrovascular disease, coronary artery disease and chronic
kidney disease, leading to premature morbidity and mortality (5). Hypertension causes 16% of
ischemic heart disease, 21% of peripheral vascular disease, 24% of heart attacks, 29% of strokes,
49% of heart failure and 10% of deaths (6, 7). Controlling hypertension requires self-care
behaviors, and encouraging the patient to engage in these behaviors can have desirable clinical
outcomes (8, 9). Self-care means maintaining one's own health, prevention and treatment of
diseases. Self-care has four components: a healthy lifestyle, treatment of minor illnesses and
diseases, disease management and chronic conditions, and care after discharge from hospital (10).
Following self-care guidelines such as losing weight, quitting smoking, eating low-sodium foods,
and exercising can play an important role in regulating and controlling blood pressure; Although the
benefits of self-care behaviors in controlling blood pressure are clear, most patients do not follow
them (11).
There are few standard tools for measuring self-care in patients with hypertension (12). Also, many
of the tools used to assess self-care in patients with hypertension (such as Hill-Bone Medication
Adherence and Morisky Medication Adherence Scale) are not comprehensive and only examine
adherence to the medication regimen, and ignore other aspects of self-care such as disease
management, diet, and activity (13). The Hypertension Self-Care Profile (HTN-SCP) has three
sections: self-care, motivation for behavior change, and self-efficacy. Each sub-section also has 20
items. Each is a 20- item Likert-type scale that assesses self-care practices (rarely/ never = 1, always
= 4), motivation for behavior change (not important = 1, very important = 4), and confidence (not
confident = 1, very confident = 4) in HTN self-care related to lifestyle modifications, medication
adherence, etc. Each of these sections is scored separately and its score varies between 20 and 80,
which means a higher score means more self-care, motivation and self-efficacy (14)
Given the importance of self-care in patients with hypertension and the need to use local and
comprehensive tools, researchers will conduct this study with the aim of translating and examining
the psychometric properties of the Kurdish version of the HTN-SCP.
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Research questions
What are the psychometric properties of the Kurdish version of HTN-SCP?
Hypothesis, objectives:
The Kurdish version of HTN-SCP has good psychometric properties.
Methods including all the major aspects
Translation process
We first asked the questionnaire designer for permission to translate the tool into Kurdish and
evaluate its psychometric properties. The translation process will begin forward-backward in such a
way that the original version will first be translated into Kurdish by two translators, the two
versions will be reviewed by the research team, and finally the final Kurdish version will be
compiled. The final Kurdish version will then be given to two other translators to translate it into
English independently. Finally, the final English version will be compiled (15). To increase the
accuracy of the study, the instrument designer has also been invited to participate in this research.
Face validity
The final Kurdish version of HTN-SCP will be distributed among 5 eligible hypertensive patients.
They are asked to carefully read and complete the questionnaire, mark the ambiguities, and write
their own sentences (16).
Content validity
After this stage, the questionnaire will be sent to 5 researchers or faculty members who are familiar
with the subject or method to review the content of the questionnaire, and their opinions will be
applied after the agreement of the research team (17).
Construct validity
Exploratory and confirmatory factor analysis is used to evaluate construct validity. Factor analysis
examines the internal relationship of a large number of variables with the aim of discovering the
categories of variables that are most related to each other (18).
Reliability
Cronbach's alpha coefficient will be calculated to evaluate the reliability. Due to the limitations of
this method (which is affected by the sample size and number of items) (19), the internal
consistency with the McDonald omega coefficient will also be calculated (20).
Ethical considerations
The proposal of this research project will be reviewed and approved by the komar research
committee. After the approval of the university ethics committee and obtaining the code of ethics,
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the researchers will receive a letter of introduction from the university. The objectives of the study
will be explained to the participants and their consent to participate in this research will be obtained.
Questionnaires will be distributed anonymously among patients in hospitals or hypertension clinics.
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II) FULL PROPOSAL – Check how long this should be and stick to the guidelines
1. LITERATURE REVIEW:
• In a cross-sectional study, Niriayo et al. (2019) examined the self-care status of patients with
hypertension in Ethiopia. The study sample consisted of 276 patients referred to a cardiac
clinic. The Self-Care Activity Level Effects (H-SCALE) questionnaire was used to collect
data. The results showed that less than half of the patients followed antihypertensive drugs
(48.2%) and recommended physical activity (44.9%). Also, 21.45% and 29% of patients
followed weight management and low-salt diet, respectively. There was a relationship
between treatment adherence with rural settlement variables (95% CI: 0.21-0.97, AOR =
0.45), underlying diseases (95% CI: 0.08-0.31, AOR = 0.16) and negatively attitude to
treatment (95% CI: 0.14-0.46, AOR = 0.25) (1).
• In a cross-sectional study, Ko et al. (2016) tested the reliability of the HTN-SCP instrument
on Singaporean patients. 160 patients completed the questionnaire and 71 test-retest answers
were completed. The results showed that there was no ceiling or floor effect in the three
subscales. Cronbach's alpha dimensions of behaviour, motivation and self-care were 0.857,
0.948 and 0.931, respectively. Also, the item-total correlation was 0.55 to 0.656 for the
behaviour dimension, 0.401 to 0.880 for the motivation dimension, and 0.349 to 0.789 for
the self-efficacy dimension. Also, the ICC for these three dimensions was 0.671, 0.762 and
0.720, respectively (21).
• In a study, Silveira et al. (2017) examined the cross-cultural adaptation of self-care tools.
The study sample consisted of 110 patients with hypertension (40 patients for pre-test, 30
for interobserver agreement testing and 40 for stability testing). The results showed
Interobserver analysis demonstrated substantial agreement (range, 0.69-0.96; 95%
confidence interval, 0.42-1.12). The temporal stability analysis demonstrated agreement
between the 2 time points of administration (range, 0.81-1.00; 95% confidence interval,
0.69-1.19) (22).
• Anne et al. (2017) conducted a study to evaluate the psychometric properties of the Korean
version of the self-care tool. Forward-Backward translation was done by bilingual nursing
and nutritionists. The study sample consisted of 196 patients with hypertension. Content,
construct and concurrency validity and reliability were performed. The results of the
analysis showed that 20 items of self-care behaviour remained. In the exploratory factor
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analysis, two factors, HBP-SC Diet behaviour and HBP-SC Health behaviour (except diet),
were extracted, which explained 48.9% of the total variance. Reliability based on
Cronbach's alpha coefficient was 0.92 (23).
• In a cross-sectional study, Kass et al. (2020) examined the psychometric properties of the
Turkish version of the self-care instrument in patients with hypertension. The translation
process was done as a forward-backward. The samples included 200 patients with a mean
age of 58.2 years, 50.5% of whom were women. The mean duration of hypertension in these
patients was 11 ± 9.4 years. In the self-care questionnaire, Cronbach's alpha coefficient for
internal consistency was 0.938 and ICC for test-retest was 0.730. Also, item-total score
correlations ranged from 0.539 to 0.742. In the motivation questionnaire, Cronbach's alpha
coefficient for internal consistency was 0.937 and ICC for test-retest was 0.758. Also, item-
total score correlations ranged from 0.491 to 0.758. In the self-efficacy questionnaire,
Cronbach's alpha coefficient for internal consistency was 0.942 and ICC for test-retest was
0.766. Also, item-total score correlations ranged from 0.526 to 0.728. Exploratory factor
analysis was performed to evaluate the construct validity. For self-care, Kaiser Meyer-Alkin
index was 0.935, which indicates the adequacy of sampling. Bartlett test was significant (X2
= 2018.22; P <0.001). In exploratory factor analysis, one factor was extracted that explained
46.32% of the total variance of HBP-SCP-Behaviour Scale. The factor load of the items was
0.617 to 0.778. For HBP SCP – Motivation Scale, KMO index was 0.939 and Bartlett test
was significant (X2 = 1,971.61, P <.001). In factor analysis of this section, a factor was
extracted that explained 45.87% of the total variance. The universal load of the items was
0.536 to 0.796. For HBP SCP – Motivation Scale, KMO index was 0.941 and Bartlett test
was significant (X2 = 2,137.31, P <0.001). In factor analysis of this section, four factors
were extracted that explained 48.08% of the total variance. The global load of items was
0.562 to 0.765. In confirmatory factor analysis, all indicators showed a good fit of the final
model (24).
Research question
1. What are the demographic characteristics of the studied samples?
2. What are the psychometric properties of the Kurdish version of HTN-SCP?
3. Does the Kurdish version of HTN-SCP have face validity?
4. Does the Kurdish version of HTN-SCP have content validity?
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Hypothesis
1. The Kurdish version of HTN-SCP is valid.
2. Is the Kurdish version of HTN-SCP reliable?
3. STUDY METHODS
Study setting
The study population is the residents of Sulaymaniah city. Because patients with high blood
pressure who go to hospitals are often in the acute phase of the disease or need medical care, we
perform sampling in public places such as markets, cafes, parks and clinics instead of hospitals.
Study design
This cross-sectional and methodological study evaluates the psychometric properties of Kurdish
version of HTN-SCP.
Sampling
For this purpose, two researchers take samples in public places via convenience sampling.
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Sample size and power
To assess the construct validity (exploratory factor analysis), 3 to 10 samples per item are required
(exploratory factor analysis), and the sample size for confirmatory factor analysis should not be less
than 200 samples (25). Considering five samples for each item, we will need 300 patients for
exploratory factor analysis and 200 samples for confirmatory factor analysis (500 patients totally).
• Hypertension
Theoretical definition: Hypertension is defined as a systolic blood pressure (SBP) of 140 mm Hg or
more, or a diastolic blood pressure (DBP) of 90 mm Hg or more, or taking antihypertensive
medication (26).
Practical definition: In this study, hypertension refers to a patient who has been diagnosed with
hypertension and is taking antihypertensive drugs to control the disease.
• Psychometric properties
Theoretical definition: Psychometric properties refer to the validity and reliability of the
measurement tool. Before being able to state that a questionnaire has excellent psychometric
properties, meaning a scale is both reliable and valid, it must be evaluated extensively (27).
Practical definition: The purpose of psychometrics in this study is to evaluate the face validity,
content validity, construct validity and reliability of the Kurdish version of HTN-SCP.
• Self-care
Theoretical definition: According to the World Health Organization, self-care means “the ability of
individuals, families and communities to promote health, prevent disease, maintain health, and to
cope with illness and disability with or without the support of a healthcare provider”(28).
Practical definition: Self-care refers to the score that hypertensive patients get from HTN-SCP. A
higher score is better and more desirable as self-care.
Data collection
Data are collected using a demographic form and a self-care questionnaire. Demographic
information includes age, sex, occupation, marital status, education, duration of illness. The
Hypertension Self-Care Profile (HTN-SCP) has three sections: self-care, motivation for behavior
change, and self-efficacy. Each sub-section also has 20 items. Each is a 20- item Likert-type scale
that assesses self-care practices (rarely/ never = 1, always = 4), motivation for behavior change (not
important = 1, very important = 4), and confidence (not confident = 1, very confident = 4) in HTN
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self-care related to lifestyle modifications, medication adherence, etc. Each of these sections is
scored separately and its score varies between 20 and 80, which means a higher score means more
self-care, motivation and self-efficacy (14).
Data management
After completing the questionnaires, their information will be entered into SPSS18 software.
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6. COMMUNICATION AND DISSEMINATION
The existence of a Kurdish version of the self-care tool allows Kurdish researchers to use a
standard, valid, and reliable Kurdish version that is easier for these patients to understand.
7. STUDY MANAGEMENT
Regulatory aspects
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8. REFERENCES
1. Listed below are common recommendations for persons with hypertension. How often do
you do the following?
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salt products (e.g. homemade soups, fresh
vegetables)?
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(e.g. deep breathing, meditation)?
2. Listed below are common recommendations for persons with hypertension. How
important is it to you to do the following?
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C31. Limit total calorie intake from fat (less 4 3 2 1
than 65grams) daily?
3. Listed below are common recommendations for persons with hypertension. How
confident are you that you could,
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per day (6 grams)?
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